Heart FailureNCT02299960
Measurement of Endothelial Function and Cardiac Output: New Methods
An observational study of Heart Failure and Hypertension, Pulmonary, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Heart Failure, Hypertension, Pulmonary, Hypertension
- What is being tested?
- Endo-PAT and NICOM
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from the conditions stated above
Who may be able to join
- Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
- Signed consent form
- HFpEF:
- Baseline-Echocardiography:
- hospitalization <= 12 months with diagnosis heart failure and E/E' > 8 or E' < 8 cm/s or
- BNP >= 100pg/ml or NT-proBNP >= 300pg/ml in the last 6 months or
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- LAVI > 28 ml/m² and E/E' > 8 or E' < 8cm/s or PAPsys > 40mmHg and E/E' > 8 or E' < 8 cm/s
- Possibility to take part in cardiac stress test
- Heart failure NYHA I-III
- Sinus rhythm
- Max. O2-uptake on exertion < 20ml/kgBW/min
- HFrEF
- HFrEF due to ischemic or non-ischemic reasons
- NYHA I-III
- Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)
- EF <=45%, Simpson Biplan PH
- NICE-Classification 2013 I/II
- PAH >= 25 mmHg
- Precapillary PAH: Wedge-pressure <= 15 mmHg, CO normal or low
- Postcapillary PAH: Wedge-pressure >= 15 mmHg, CO normal or low
- Diabetic nephropathy:
- Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:
- Diabetic nephropathy has been diagnosed before (anamnesis)
- Macroalbuminuria: Urine Albumine/Creatinine-ratio > 300mg/g Creatinine (>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR <90ml/min/1.73m² (CKD-EPI)
- Microalbuminuria: 30-300mg/g Creatinine (>=3.4 mg/mmol but <34mg/mmol) tested as above and GFR < 90 ml/min/1.73m² and diabetic retinopathy
- AH:
- Hypertension diagnosed at least 6 months except structural heart disease: EF > 55% and no sign of HFpEF
- No symptoms of coronary heart disease
- Possibility to take part in cardiac stress test
- Stable pharmacologic therapy of Hypertension for at least 4 weeks
- Systolic blood pressure <140 mmHG during Screening
Who cannot join
- Patient incapable of contracting
- Angina pectoris > CCS II
- Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
- Myocardial infarction in the last 3 months
- Stroke in the last 3 months
- Valvular heart disease > II°
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- Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)
- Congenital complex heart disease
- Active myocarditis
- Significant lung disease
- Significant Cardiac dysrhythmia
- Scheduled changes in medication during time of study
- (Scheduled) heart transplant
- Cardiac resynchronisation therapy over the last three months
- ICD/Pacemaker-implant in the last 4 weeks
- Uncontrolled Hyper/Hypotension (>180mmHg, <95mmHg)
- Patient taking part in Rehabilitation program
- Diagnosed Malignant disease or disease with life expectancy < 1 year
- Anemia with Hb<10mg/dl
- Untreated significant thyroid disease
- HFpEF, Hypertension and PH:
- Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)
- Significant changes in cardiovascular Status over the two weeks of study
- Instable cardiopulmonary Status over the last four weeks
- HFrEF:
- I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening
- Myocardial infarction in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Analysis of Endothelial Function Through Circulating Endothelial Cells and Puls-amplitude-tonometry and of Non-invasive Measurement of Cardiac Output on Exertion in Patients With Heart Failure, Pulmonary Hypertension, Arterial Hypertension and Diabetic Nephropathy
The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.
- Being tested
- Endo-PAT, NICOM
- Keywords
- EndoPAT, NICOM, circulating endothelial cells
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary, Hypertension, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-PATDevice
Analysis of endothelial function through pulse-amplitude-tonometry
NICOMDevice
Non-invasive measurement of cardiac output
| Study group | Role | What they receive |
|---|---|---|
| HFpEF | patients with heart failure with preserved ejection fraction Receives: Device: Endo-PAT; Device: NICOM | |
| HFrEF | patients with heart failure with reduced ejection fraction Receives: Device: Endo-PAT | |
| AH | patients with hypertension Receives: Device: Endo-PAT; Device: NICOM | |
| Nephropathy | patients with diabetic nephropathy Receives: Device: Endo-PAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest-reliability EndoPAT
Measured: 2 weeks
Secondary outcomes (7)
Test-retest-reliability circulating endothelial cells
Measured: 2 weeks
Test-retest-reliability NICOM
Measured: 2 weeks
Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test
Measured: 2 weeks
Correlation: circulating endothelial cells and EndoPAT and endothelial function
will include the molecular diagnostic of circulating endothelial cells
Measured: 2 weeks
Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome
Measured: 2 weeks
Correlation cardiac Output on exertion and echocardiography in HFpEF
Measured: 2 weeks
Clinical feasibility of circulating endothelial cells and EndoPAT
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Health Twist GmbH
- Responsible party
- Principal investigator, Sebastian Beckmann, Charite University, Berlin, Germany
- Investigators
- Hans-Dirk Duengen, PD Dr. med., Study chair, Charite Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299960
- Sponsor's protocol ID
- ENDO-CEC
- Status last verified
- Jun 2016
- First submitted
- 20 Nov 2014
- Last updated
- 10 Jun 2016
- Results posted
- No
Publications
Weisrock F, Fritschka M, Beckmann S, Litmeier S, Wagner J, Tahirovic E, Radenovic S, Zelenak C, Hashemi D, Busjahn A, Krahn T, Pieske B, Dinh W, Dungen HD. Reliability of peripheral arterial tonometry in patients with heart failure, diabetic nephropathy and arterial hypertension. Vasc Med. 2017 Aug;22(4):292-300. doi: 10.1177/1358863X17706752. Epub 2017 May 30.
PubMed 28555533
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Analysis of Endothelial Function Through Circulating Endothelial Cells and Puls-amplitude-tonometry and of Non-invasive Measurement of Cardiac Output on Exertion in Patients With Heart Failure, Pulmonary Hypertension, Arterial Hypertension and Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT02299960
- Acronym / sponsor ID
- ENDO-CEC
- Keywords
- EndoPAT, NICOM, circulating endothelial cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Bayer, Health Twist GmbH
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | Device: Endo-PAT, Device: NICOMpatients with heart failure with preserved ejection fraction |
| HFrEF | – | Device: Endo-PATpatients with heart failure with reduced ejection fraction |
| AH | – | Device: Endo-PAT, Device: NICOMpatients with hypertension |
| Nephropathy | – | Device: Endo-PATpatients with diabetic nephropathy |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from the conditions stated above
Key inclusion criteria (31 listed)
- Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
- Signed consent form
- Baseline-Echocardiography:
- hospitalization <= 12 months with diagnosis heart failure and E/E' > 8 or E' < 8 cm/s or
- BNP >= 100pg/ml or NT-proBNP >= 300pg/ml in the last 6 months or
Key exclusion criteria (27 listed)
- Patient incapable of contracting
- Angina pectoris > CCS II
- Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
- Myocardial infarction in the last 3 months
- Stroke in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endo-PATAnalysis of endothelial function through pulse-amplitude-tonometry | Device | AH, HFpEF, HFrEF, Nephropathy |
| NICOMNon-invasive measurement of cardiac output | Device | AH, HFpEF |
Primary outcome
Test-retest-reliability EndoPAT
Time frame: 2 weeks
7 secondary outcomes
Test-retest-reliability circulating endothelial cells
Time frame: 2 weeks
Test-retest-reliability NICOM
Time frame: 2 weeks
Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test
Time frame: 2 weeks
Correlation: circulating endothelial cells and EndoPAT and endothelial function
Time frame: 2 weeks
Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome
Time frame: 2 weeks
Correlation cardiac Output on exertion and echocardiography in HFpEF
Time frame: 2 weeks
Clinical feasibility of circulating endothelial cells and EndoPAT
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Derived from this study: PubMed 28555533Weisrock F, Fritschka M, Beckmann S, Litmeier S, Wagner J, Tahirovic E, Radenovic S, Zelenak C, Hashemi D, Busjahn A, Krahn T, Pieske B, Dinh W, Dungen HD. Reliability of peripheral arterial tonometry in patients with heart failure, diabetic nephropathy and arterial hypertension. Vasc Med. 2017 Aug;22(4):292-300. doi: 10.1177/1358863X17706752. Epub 2017 May 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Dirk Duengen, PD Dr. med. study chair
Charite Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Hypertension, Pulmonary, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest-reliability EndoPAT (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.